 Thank you, Eric. So the policy branch and the Centers for Devices and Radiological Health collaborated to develop an educational workshop with the goal of raising awareness about the IDE process and how it applies to those working in genomic research. As you can see by the agenda, the day is structured to introduce you to the IDE process and address the decision points that occur throughout the process. The sessions, we structured the sessions to have presentations from FDA as well as a researcher and IRB perspective so we can have a few PowerPoints discussing background and then interaction between FDA and their perspective to address any gaps or questions that may exist. After the presentations in each session, there will be time for discussions and questions about the IDE process. Reiterating what Eric stated earlier, at the end of the day, we hope to have provided you with practical information about FDA IDE regulations, when they apply, and how you can successfully fulfill these requirements when carrying out genomics research specifically. I'd like to thank all of the speakers who generously gave their time today. Our FDA collaborators for all of their input and help in putting today's workshop together. And I'd especially like to thank Rebecca Hong, the woman who you have all heard from at least three times in your email inbox, and without her today's workshop wouldn't have been possible. So we have a few housekeeping items. This meeting is being live streamed and recorded. The workshop will be provided online along with all of today's slides for future reference. The online will be in distinct individual modules, so if you'd like to just look at analytical validity or determining risk, you can look at each separate session, so we're dividing this to be modular in the future. And all of the slides will also be online after the fact for future reference. And you'll find these materials and footage from today at www.genome.gov.com. And a few logistical things. Restrooms are on this floor and outside of the door we have signs posted to guide you. If you're in need of a caffeine boost, there's a cafeteria on one floor up, which is also an option for our lunch break. And we're looking forward to an educational and informative day, and we thank all of you here and online for joining us. Now I'd like to introduce Dr. David Litwak from the Office of Personalized Medicine and the Centers for Devices and Radiological Health at FDA. Dr. Litwak develops policies to guide the review of investigational biomarker tests, companion diagnostics, and next generation technologies at FDA. And he will be discussing the policy context of IDEs. David.